EP3981335B1 - Biopsy device - Google Patents

Biopsy device Download PDF

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Publication number
EP3981335B1
EP3981335B1 EP21211318.7A EP21211318A EP3981335B1 EP 3981335 B1 EP3981335 B1 EP 3981335B1 EP 21211318 A EP21211318 A EP 21211318A EP 3981335 B1 EP3981335 B1 EP 3981335B1
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EP
European Patent Office
Prior art keywords
cannula
slide
spring
vacuum
carriage
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP21211318.7A
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German (de)
English (en)
French (fr)
Other versions
EP3981335C0 (en
EP3981335A1 (en
Inventor
Chad Van Liere
Rory M. Schlarb
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CR Bard Inc
Original Assignee
CR Bard Inc
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Priority to EP21211318.7A priority Critical patent/EP3981335B1/en
Publication of EP3981335A1 publication Critical patent/EP3981335A1/en
Application granted granted Critical
Publication of EP3981335B1 publication Critical patent/EP3981335B1/en
Publication of EP3981335C0 publication Critical patent/EP3981335C0/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0225—Instruments for taking cell samples or for biopsy for taking multiple samples

Definitions

  • the present invention relates to biopsy devices, and, more particularly, to a handheld biopsy device having integrated vacuum assist to aid in tissue sample acquisition.
  • a biopsy device has a sample retrieval mechanism configured to sever and remove a tissue sample from a patient.
  • the sample retrieval mechanism may be in the form of a biopsy probe assembly that is configured with a biopsy needle having a sample retrieval opening.
  • a typical partially disposable biopsy device has a reusable handheld driver to which a disposable probe is releasably attached.
  • the reusable handheld driver is typically battery powered, and includes electrical motor drives and an on-board vacuum pump to aid in sample acquisition and/or retrieval.
  • Such biopsy devices are configured for single insertion multiple sample (SIMS) procedures.
  • SIMS single insertion multiple sample
  • a typical fully disposable biopsy device has one or more mechanical drives, such as spring/latch arrangements, which permit the biopsy device to be manually cocked and fired for tissue sample acquisition.
  • Such simple biopsy devices often are configured to acquire a single sample per insertion.
  • many of the fully disposable biopsy devices do not have vacuum to assist in sample acquisition. While some attempts have been made to include a vacuum assist feature in a fully disposable biopsy device, the vacuum produced typically is not sufficient to approach the performance of that of a partially disposable biopsy device as described above. Also, in a typical fully disposable biopsy device having vacuum assist, such vacuum is generated simultaneously with movement of the cutting cannula to sever the tissue sample, and thus the vacuum may be of limited value in acquiring the tissue sample.
  • Patent publication US 2004/158172 A1 discloses an automatic tissue sampling apparatus for use with a biopsy needle set including an inner needle having a first hub disposed at one end and a cutting point disposed on an opposite end with a tissue holding notch positioned between the cutting point and the first hub and an outer cannula having a second hub at one end and a cutting point disposed at the opposite end.
  • a biopsy device that may be fully disposable, and which may generate a reserve of vacuum prior to a retraction of the cutting cannula to expose the sample retrieval opening of the biopsy needle, thus facilitating efficient vacuum application to aid in sample acquisition, and which is configured to be easy to use.
  • the present invention provides a biopsy device as defined in independent claim 1. Also disclosed is a method of operating the biopsy device.
  • first, second, third, etc. that precede an element name, e.g., first latch member, second latch member, etc., are for identification purposes to distinguish between different elements having similar characteristic, and are not intended to necessarily imply order, unless otherwise specified, nor are such terms intended to preclude the inclusion of additional similar elements.
  • a biopsy device having a housing, a biopsy needle including a stylet and a cannula, a carriage assembly including a carriage slide, a cannula slide and a sampling slide.
  • the carriage slide has a stylet mount end wall and the cannula slide has a cannula mount end wall.
  • a charge handle is slidably mounted to the housing.
  • the charge handle has a home position and a retracted position.
  • the biopsy device further includes a vacuum system positioned in the housing and carried by the carriage assembly. The vacuum system is charged to generate a vacuum when a sampling spring is compressed.
  • the vacuum system includes a first vacuum pump, a second vacuum pump, a manifold and a control valve.
  • the first vacuum pump has a first vacuum port.
  • the second vacuum pump has a second vacuum port.
  • the manifold has a first vacuum draw port, a second vacuum draw port, and a first vacuum application port.
  • the control valve has a third vacuum draw port and a second vacuum application port.
  • the first vacuum port of the first vacuum pump is coupled in fluid communication with the first vacuum draw port of the manifold.
  • the second vacuum port of the second vacuum pump is coupled in fluid communication with the second vacuum draw port of the manifold.
  • the first vacuum application port of the manifold is coupled in fluid communication with the third vacuum draw port of the valve.
  • the second vacuum draw port of the control valve is coupled in fluid communication with a first lumen of the stylet.
  • the manifold has a first one-way valve coupled in fluid communication with the first vacuum draw port and a second one-way valve coupled in fluid communication with the second vacuum draw port.
  • Each of the first one-way valve and the second one-way valve is configured to release positive pressure to the atmosphere and to close upon establishment of vacuum.
  • the control valve is operated by actuation of a cannula retract button of an actuator mechanism to apply the vacuum to a side sample port of the stylet simultaneously with movement of the cannula in a proximal direction by a force generated by a cannula retract spring to open the side sample port of the stylet.
  • a biopsy device that includes a housing having an actuator mechanism.
  • a carriage assembly is movable relative to the housing.
  • the carriage assembly includes a stylet mount wall that mounts a stylet having a sample port, a cannula slide that mounts a cutting cannula, a sampling slide movably interposed between the stylet mount wall and the cannula slide, and a carriage latch cover member.
  • the cannula slide is longitudinally spaced from and movable relative to the stylet mount wall.
  • the cannula slide has a first latch member, the sampling slide has a second latch member, and the carriage latch cover member has a third latch member.
  • a charge handle is slidably mounted to the housing. The charge handle has a home position and a retracted position.
  • a sampling spring is interposed between the stylet mount wall and the sampling slide.
  • a cannula retract spring is interposed between, and connected to each of, the sampling slide and the cannula slide.
  • a prime pierce spring is interposed between the carriage assembly and a portion of the housing.
  • a vacuum system is configured to selectively supply a vacuum to the sample port of the stylet.
  • the biopsy device is configured such that a first retraction of the charge handle moves the cannula slide and the sampling slide in unison in a proximal direction to charge the sampling spring, to latch the second latch member of the sampling slide with the carriage latch cover member to retain the sampling spring in a charged state, and to charge the vacuum system to generate the vacuum.
  • a first return of the charge handle returns the charge handle to the home position.
  • a second retraction of the charge handle moves the charge handle to the retracted position.
  • a second return of the charge handle to the home position moves the cannula slide in a distal direction away from the sampling slide to charge the cannula retract spring and to latch the first latch member of the cannula slide with the carriage latch cover member to retain the cannula retract spring in a charged state.
  • a third retraction of the charge handle moves the carriage assembly as a whole in the proximal direction to charge the prime pierce spring and to latch the third latch member of the carriage latch cover member with the actuator mechanism to retain the prime pierce spring in a charged state.
  • the invention in another form is directed to a biopsy device that includes a stylet positioned to extend on a longitudinal axis.
  • the stylet has a first side wall configured to define a first lumen and a side sample port that extends through the first side wall to the first lumen.
  • a cannula is coaxial with the stylet.
  • the cannula has a second side wall configured to define a second lumen and a distal cutting edge.
  • a housing has a proximal end wall, an intermediate wall, and a distal end portion spaced along the longitudinal axis.
  • the distal end portion has a needle opening.
  • the housing is configured to define a housing chamber between the proximal end wall and the distal end portion.
  • the intermediate wall is interposed between the proximal end wall and the distal end portion.
  • the stylet and the cannula are received through the needle opening.
  • a proximal direction is from the distal end portion toward to the proximal end wall and a distal direction is from the proximal end wall toward the distal end portion.
  • a charge handle is slidably mounted to the housing. The charge handle is configured to move between a home position and a retracted position.
  • An actuator mechanism has a pierce button, a cannula retract button, and a sample acquisition button, and has a carriage latch strike.
  • a carriage assembly is positioned in the housing chamber. The carriage assembly is configured to move longitudinally as a whole relative to the housing.
  • the carriage assembly includes a carriage slide, a carriage latch cover member, a cannula slide, and a sampling slide.
  • Each of the cannula slide and the sampling slide is configured to be movable relative to the carriage slide.
  • the carriage slide has a stylet mount end wall configured to mount the stylet.
  • the cannula slide has a cannula mount end wall configured to mount the cannula and has a first latch arm that extends in the proximal direction from the cannula mount end wall.
  • the sampling slide is movably interposed between the stylet mount end wall of the carriage slide and the cannula mount end wall of the cannula slide.
  • the sampling slide has a second latch arm that extends in the distal direction.
  • the carriage latch cover member has a first latch strike, a second latch strike, and a carriage latch arm.
  • the first latch strike is configured to releasably engage the first latch arm.
  • the second latch strike is configured to releasably engage the second latch arm.
  • the carriage latch arm is configured to releasably engage the carriage latch strike of the actuator mechanism.
  • a sampling spring is interposed between the stylet mount end wall and the sampling slide. The sampling spring is configured to store mechanical energy when in a compressed state and configured to bias the sampling slide in the distal direction. The sampling spring is held in the compressed state when the second latch arm is engaged with the second latch strike.
  • a vacuum system is positioned in the housing and carried by the carriage assembly. The vacuum system is charged to generate a vacuum when the sampling spring is compressed.
  • a cannula retract spring is interposed between, and is connected to each of, the sampling slide and the cannula slide.
  • the cannula retract spring is configured to store mechanical energy in an extended state to bias the cannula slide in the proximal direction.
  • the cannula retract spring is releasably held in the extended state when the first latch arm is engaged with the first latch strike and the second latch arm is engaged with the second latch strike.
  • a prime pierce spring is interposed between the intermediate wall of the housing and the stylet mount end wall.
  • the prime pierce spring is configured to store mechanical energy when in a compressed state and is configured to bias the carriage assembly as a whole in the distal direction.
  • the prime pierce spring is held in the compressed state when the carriage latch arm is engaged with the carriage latch strike of the actuator mechanism.
  • the biopsy device also may include an indexing mechanism that is movably coupled to the cannula mount end wall of the cannula slide.
  • the cannula mount end wall has an indexing window.
  • the indexing mechanism is configured to selectively cover a portion of the indexing window.
  • the charge handle has a charge handle latch arm configured to pass through the indexing window when the charge handle is moved to the retracted position, and when the indexing mechanism is positioned to cover a portion of the indexing window, a subsequent movement of the charge handle in the distal direction toward the home position causes the charge handle latch arm to engage the indexing mechanism to move the cannula slide in the distal direction away from the sampling slide to charge the cannula retract spring.
  • a biopsy device that includes a housing having a longitudinal axis.
  • the housing is configured to define a housing chamber.
  • An actuator mechanism has a cannula retract button, a sample acquisition button, and a carriage latch strike.
  • a carriage assembly is positioned in the housing chamber.
  • the carriage assembly includes a carriage slide having a carriage base and a stylet mount wall.
  • the carriage assembly further includes a sampling slide, a cannula slide and a carriage latch cover member.
  • the cannula slide is longitudinally spaced from and movable relative to the stylet mount wall.
  • the cannula slide has a first latch arm.
  • the carriage latch cover member has a first latch strike and a second latch strike.
  • the first latch arm is configured to releasably engage the first latch strike.
  • a stylet is fixedly connected to stylet mount wall.
  • the stylet is configured to extend along the longitudinal axis, and has a side sample port.
  • a vacuum source is carried by the carriage assembly. The vacuum source is configured to selectively apply a vacuum to the side sample port of the stylet.
  • a cannula is fixedly connected to the cannula slide. The cannula is coaxial with the stylet. The cannula has a distal cutting edge.
  • the sampling slide is movably interposed between the stylet mount wall and the cannula slide.
  • the sampling slide has a second latch arm and a latch arm deflection member. The second latch arm is configured to releasably engage the second latch strike of the carriage latch cover member.
  • the latch arm deflection member is configured to engage the first latch arm of the cannula slide and deflect the first latch arm toward the carriage base.
  • a sampling spring is interposed between the stylet mount wall and the sampling slide. The sampling spring is held in the compressed state when the second latch arm is engaged with the second latch strike.
  • a cannula retract spring is interposed between, and is connected to each of, the sampling slide and the cannula slide. The cannula retract spring is releasably held in an extended state to store mechanical energy when the first latch arm is engaged with the first latch strike and the second latch arm is engaged with the second latch strike.
  • a cocking mechanism has a charge handle, a biasing spring, and an indexing mechanism.
  • the charge handle is slidably mounted to the housing and biased by the biasing spring in the distal direction to a home position.
  • the charge handle is configured to move between the home position and a retracted position.
  • the charge handle and the indexing mechanism in combination are configured to selectively move each of the sampling slide and the cannula slide based on sequential actuations of the charge handle, wherein: a first retraction of the charge handle moves the sampling slide and the cannula slide in unison in the proximal direction to compress the sampling spring, to engage the second latch arm with the second latch strike to retain the sampling spring in the compressed state, and to charge the vacuum source, the charge handle configured to return to the home position by force exerted by the biasing spring and to sequence the indexing mechanism to a next selection position; and a second retraction of the charge handle moves the charge handle to the retracted position, and during a return of the charge handle to the home position by force exerted by the biasing spring, the charge handle engages the cannula slide and
  • the actuator mechanism is configured such that an actuation of the cannula retract button releases the first latch arm from the first latch strike to in turn release the cannula retract spring to exert a retraction force to move the cannula in the proximal direction to open the side sample port of the stylet and to simultaneously apply the vacuum to the side sample port; and an actuation of the sample acquisition button releases the second latch arm from the second latch strike to release the sampling spring to exert a force to move the cannula in the distal direction to close the side sample port.
  • a method of operating a biopsy device which includes providing a housing having an actuator mechanism; providing a carriage assembly movable relative to the housing, the carriage assembly including a stylet mount wall that mounts a stylet, a cannula slide that mounts a cutting cannula, a sampling slide movably interposed between the stylet mount wall and the cannula slide, and a carriage latch cover member, the cannula slide being longitudinally spaced from and movable relative to the stylet mount wall; providing a charge handle to sequentially move at least one of the cannula slide, the sampling slide, and the carriage assembly as a whole, the charge handle having a home position and a retracted position; providing a sampling spring interposed between the stylet mount wall and the sampling slide; providing a cannula retract spring interposed between, and connected to each of, the sampling slide and the cannula slide; providing a prime pierce spring interposed between the carriage assembly and a portion of the housing; providing a vacuum system to selectively supply
  • An advantage of the present invention is that the biopsy device is fully disposable.
  • Another advantage of the present invention is that the biopsy device is fully mechanical with no electrical component, thus requiring no electrical power source.
  • another advantage is that the biopsy device generates a reserve of vacuum prior to a retraction of the cutting cannula to expose the sample port of the biopsy needle, thus facilitating efficient vacuum application to aid in sample acquisition.
  • Another advantage of the present invention is that the biopsy device is configured to be easy to use.
  • Biopsy device 10 is a self-contained and fully mechanical vacuum-assisted biopsy device that is configured as a single insertion single sample (SISS) biopsy device, and which is fully disposable.
  • SISS single insertion single sample
  • the term "disposable” is used to refer to a device that is intended to be disposed of after use on a single patient. Accordingly, biopsy device 10 is intended for use in obtaining one or more tissue samples from a single patient during a single biopsy procedure, and is intended to be disposable in its entirety at the end of the biopsy procedure.
  • biopsy device 10 includes a housing 12, a biopsy needle 14, a charge handle 16, and an actuator mechanism 18.
  • Biopsy needle 14 includes a stylet 20 and a cannula 22.
  • housing 12, charge handle 16 and actuator mechanism 18 are made of plastic
  • stylet 20 and cannula 22 are made from a metallic material, such as stainless steel.
  • proximal direction D2 is a longitudinal direction opposite to distal direction D1.
  • biopsy needle 14 extends away from housing 12 along longitudinal axis 23 in the distal direction D1.
  • Each of stylet 20 and cannula 22 of biopsy needle 14 is positioned to extend on the longitudinal axis 23.
  • cannula 22 is external to stylet 20, such that cannula 22 is arranged as the outer tube of the coaxial arrangement of stylet 20 and cannula 22.
  • Stylet 20 and cannula 22 are sized such that stylet 20 is slidably received in cannula 22 in a close sliding fit, wherein the inside diameter of cannula 22 is slightly larger than the outside diameter of stylet 20 in a tolerance range of 0.01 millimeters (mm) to 1.0 mm.
  • housing 12 includes an upper case portion 24 and a lower case portion 25.
  • Upper case portion 24 is jointed to lower case portion 25 by removable fasteners 27, such as screws.
  • Upper case portion 24 of housing 12 has an opening 24-1, and opposing upper slots 24-2, 24-3.
  • Opening 24-1 is configured to receive and mount actuator mechanism 18.
  • actuator mechanism 18 may be formed integral with upper case portion 24 of housing 12 at the location of opening 24-1.
  • Lower case portion 25 is configured with opposing guide rails 25-1, 25-2 which define a lower slot, which in conjunction with the opposing upper slots 24-2, 24-3 of upper case portion 24, slidably mount charge handle 16.
  • Upper case portion 24 and lower case portion 25 of housing 12 collectively define a proximal end wall 26 and a distal end portion 28 spaced from proximal end wall 26 along a longitudinal axis 23.
  • the distal direction D1 is in a direction from proximal end wall 26 toward distal end portion 28, e.g., in a direction of the extent of biopsy needle 14 away from housing 12 and away from the user.
  • the proximal direction D2 (opposite distal direction D1) is in a direction from distal end portion 28 toward proximal end wall 26, e.g., toward the user.
  • Housing 12 is configured to define a housing chamber 30 between proximal end wall 26 and distal end portion 28.
  • lower case portion 25 of housing 12 further includes an intermediate wall 32 that is interposed between proximal end wall 26 and distal end portion 28.
  • distal end portion 28 has a needle opening 12-1 configured to receive biopsy needle biopsy needle 14, with longitudinal axis 23 passing through needle opening 12-1 and through the longitudinal extent of biopsy needle 14.
  • Proximal end wall 26 faces the user when the user grasps the biopsy device 10 in a normal operating fashion.
  • Charge handle 16 and actuator mechanism 18 provide the user with fully accessible control features used to operate biopsy device 10 in an intuitive manner to obtain a tissue sample from suspect tissue of a patient via biopsy needle 14.
  • Charge handle 16 is used to ready biopsy device 10 for performing a biopsy procedure by facilitating the generation of vacuum and preparing biopsy needle 14 for severing and collecting the tissue sample.
  • charge handle 16 has a U-shaped charge handle body 34, a charge handle end wall 36, and a charge handle latch arm 38.
  • Charge handle latch arm 38 extends in a cantilever manner in the proximal direction D2 from charge handle end wall 36.
  • Charge handle end wall 36 laterally intersects U-shaped charge handle body 34 to define a handle mount opening 36-1 (see Fig. 5 ) having a half-circle shape located below charge handle end wall 36.
  • distal end portion 28 of lower case portion 25 is manipulated through handle mount opening 36-1, such that charge handle end wall 36 rests on the opposing guide rails 25-1, 25-2 of lower case portion 25 to slidably mount charge handle 16 in the laterally spaced lower case portion slots defined by the laterally spaced guide rails 25-1, 25-2 in conjunction with upper slots 24-2, 24-3 of upper case portion 24.
  • Charge handle latch arm 38 has a free end 38-1 having a laterally protruding catch 38-2.
  • Charge handle latch arm 38 is configured to be longitudinally rigid, and laterally resilient in a direction substantially perpendicular to the longitudinal extent of charge handle latch arm 38.
  • substantially perpendicular is a direction having a range of deviation from perpendicular of plus or minus five degrees.
  • charge handle 16 is biased in distal direction D1 by a biasing mechanism formed by at least one biasing spring, and in the present embodiment, includes a pair of biasing springs 39-1, 39-2 interposed between housing 12 and charge handle 16.
  • biasing springs 39-1, 39-2 are coil springs having a contracted relaxed state.
  • biasing spring 39-1 is attached at its ends to spring attachment loop 25-3 of lower case portion 25 of housing 12 (see Figs. 4 and 5 ) and to spring attachment loop 36-2 of charge handle end wall 36 of charge handle 16 (see Fig. 6 ).
  • biasing spring 39-2 is attached at its ends to spring attachment loop 25-4 of lower case portion 25 of housing 12 (see Figs.
  • Charge handle 16 is configured to be grasped by a user's hand and to move between a home (distal) position, as depicted in Figs. 1-3 , and a retracted (proximal) position.
  • actuator mechanism 18 is used to initialize the sequential operations of firing the biopsy needle in distal direction D1 to perform a piercing shot into tissue to be biopsied, to apply vacuum and open a sample port in biopsy needle 14, and to operate biopsy needle 14 to sever a tissue sample, as more fully described below.
  • actuator mechanism 18 includes three control buttons 40, individually identified as a pierce button 40-1, a cannula retract button 40-2, and a sample acquisition button 40-3, each of which is accessible to the user from the exterior of biopsy device 10.
  • each of the control buttons 40 includes a mechanical extension that serves as respective actuator portions 42-1, 42-2, 42-3.
  • actuator mechanism 18 further includes a carriage latch strike 44.
  • carriage latch strike 44 is configured as an inverted ramp having a downwardly facing ramp surface 44-1 that diverges in the proximal direction D2 to define a proximal end face 44-2.
  • biopsy device 10 further includes a carriage assembly 50 that is positioned and slidably contained in housing chamber 30 of housing 12.
  • Carriage assembly 50 is configured to move longitudinally along longitudinal axis 23 as a whole relative to housing 12, and is configured to mount biopsy needle 14, as more fully described below.
  • carriage assembly 50 includes a prime pierce carriage 52, a cannula slide 58, a sampling slide 56, and a vacuum system 54.
  • prime is used to mean a function associated with readying, i.e., cocking, biopsy device 10 for performing a tissue piercing function by having both stylet 20 and cannula 22 retracted in preparation for "piercing".
  • pierce is used to mean a function associated with firing stylet 20 and cannula 22 simultaneously in distal direction D1 such that biopsy needle 14 punctures the tissue of a patient at the desired location.
  • each of prime pierce carriage 52, cannula slide 58, and sampling slide 56 are configured to move along a substantially linear path.
  • substantially linear path is a path having a range of deviation from a straight line of plus or minus three degrees along the length of the path.
  • prime pierce carriage 52 includes carriage slide 60 serving as a lower prime pierce carriage portion and a carriage latch cover member 62 serving as an upper prime pierce carriage portion.
  • sampling slide 56 and cannula slide 58 are individually, as well as collectively, longitudinally movable relative to prime pierce carriage 52 formed by carriage slide 60 and carriage latch cover member 62.
  • Each of prime pierce carriage 52, sampling side 56 and cannula slide 58 is formed of plastic.
  • Carriage slide 60 of prime pierce carriage 52 of carriage assembly 50 has a carriage base 64 and a stylet mount end wall 66.
  • carriage base 64 and stylet mount end wall 66 are formed as a unitary carriage structure.
  • Carriage base 64 of carriage slide 60 is configured to define a U-shaped wall 64-1 having a U-shaped exterior surface 64-2 and a U-shaped interior surface 64-3, thus having a U-shaped cross-section that extends in the distal direction D1 from stylet mount end wall 66 to define a U-shaped distal edge 64-4, a pair of laterally spaced upper mounting edges 64-5, 64-6, and a pair of laterally spaced recessed slot edges 64-7, 64-8.
  • Extending upwardly and proximally from U-shaped interior surface 64-3 is a longitudinally oriented prime pierce spring mount post 64-9.
  • U-shaped exterior surface 64-2 corresponds to the interior shape of housing chamber 30, and is in sliding contact with housing chamber 30, with housing chamber 30 serving as a longitudinal guide for carriage assembly 50.
  • U-shaped distal edge 64-4 defines an open distal end 60-1 of carriage slide 60.
  • the pair of laterally spaced upper mounting edges 64-5, 64-6 in conjunction with the pair of laterally spaced recessed slot edges 64-7, 64-8 further define an open top 60-2 of carriage slide 60.
  • Stylet mount end wall 66 has a stylet hole 66-1, a first pump mounting opening 66-2 and a second pump mounting opening 66-3, and a prime pierce spring opening 66-4.
  • Prime pierce spring opening 66-4 is axially aligned with prime pierce spring mount post 64-9 of carriage base 64 of carriage slide 60.
  • Stylet hole 66-1 is configured to fixedly mount stylet 20, e.g., by a press fit and/or adhesive coupling.
  • First pump mounting opening 66-2 and second pump mounting opening 66-3 are configured to mount a pair of syringe-type vacuum pumps of vacuum system 54, as will be more fully described below.
  • stylet 20 of biopsy needle 14 has a side wall 20-1 configured to define a lumen 20-2 and a side sample port 20-3 that extends through side wall 20-1 to lumen 20-2.
  • Stylet 20 has an open first end 20-4 and a closed second end 20-5. The closed second end 20-5 defines a distal piercing tip.
  • Lumen 20-2 is in fluid communication with the open first end 20-4 and side sample port 20-3.
  • a proximal portion 20-6 of stylet 20 extends in a proximal direction D2 away from stylet mount end wall 66 and a distal portion 20-7 of stylet 20 extends in the distal direction D1 away from stylet mount end wall 66.
  • the distal portion 20-7 of stylet 20 extends in the distal direction D1 beyond the distal extent of carriage base 64 and carriage latch cover member 62, and is received through needle opening 12-1 of housing 12 (see also Fig. 1 ).
  • Carriage latch cover member 62 is configured to attach, e.g., a snap fit and/or adhesive, to the pair of laterally spaced upper mounting edges 64-5, 64-6 of carriage base 64.
  • Carriage latch cover member 62 includes laterally spaced recessed slot edges 62-1, 62-2 that are respectively vertically opposed to the laterally spaced recessed slot edges 64-7, 64-8 of carriage base 64.
  • Carriage latch cover member 62 covers the open top 60-2 of carriage slide 60, and extends over carriage base 64 of carriage slide 60 to define an interior region in which cannula slide 58 may move longitudinally relative to stylet mount end wall 66.
  • the U-shaped interior surface 64-3 of U-shaped wall 64-1 of carriage slide 60 in conjunction with open distal end 60-1 of carriage slide 60 are configured to slidably receive and longitudinally guide sampling slide 56 and cannula slide 58.
  • Carriage latch cover member 62 is configured to facilitate a selective longitudinal coupling and uncoupling of carriage slide 60 with each of sampling slide 56 and cannula slide 58.
  • Carriage latch cover member 62 has a latch strike 70, a latch strike 72, a carriage latch arm 74, and a deflector arm 76.
  • Carriage latch cover member 62 further includes conduit mounts 62-3, 62-4.
  • each of latch strike 70 and latch strike 72 is configured as a latching notch. More particularly, each of latch strike 70 and latch strike 72 of carriage latch cover member 62 is configured as a rectangular opening having proximal and distal end walls oriented to be substantially perpendicular to longitudinal axis 23.
  • Carriage latch arm 74 is configured as a cantilever arm with a free end having an upwardly extending catch 78.
  • Catch 78 is configured as ramp having an upwardly facing ramp surface 78-1 that diverges in the distal direction D1 to define a distal end face 78-2.
  • Carriage latch arm 74 is configured to be longitudinally rigid, and vertically resilient in directions D3, D4 (e.g., up, down) substantially perpendicular to the longitudinal extent of carriage latch arm 74.
  • Directions D3 and D4 are opposite directions.
  • carriage latch arm 74 of carriage latch cover member 62 releasably engages the proximal end face 44-2 of carriage latch strike 44 of actuator mechanism 18 (see Fig. 7B ) so as to couple, and prohibit relative movement between, carriage assembly 50 and housing 12, until carriage latch arm 74 is released by operation of pierce button 40-1 of actuator mechanism 18.
  • deflector arm 76 of carriage latch cover member 62 is configured to be longitudinally rigid, and also is laterally rigid in directions substantially perpendicular to the longitudinal extent of deflector arm 76.
  • Deflector arm 76 is configured as a cantilever arm having a free end having a downwardly facing deflector head 80.
  • Deflector head 80 has a downwardly facing ramp surface 80-1 that diverges in the distal direction D1 and terminates at a downwardly facing longitudinal surface 80-2.
  • vacuum system 54 is mounted to, and carried by, carriage assembly 50, and is a completely self-contained within housing 12 of biopsy device 10. More particularly, referring also to Fig. 10 , vacuum system 54 is mounted to prime pierce carriage 52 of carriage assembly 50.
  • vacuum system 54 includes a vacuum pump 90, a vacuum pump 92, a manifold 94, a control valve 96, and flexible connection conduits 98-1, 98-2, 98-3, and 98-4.
  • vacuum pump 90 is a syringe-type vacuum pump.
  • Vacuum pump 90 includes an elongate cylinder 100 having a first end 100-1 and a second end 100-2. Extending from first end 100-1 is a tip portion 100-3 that defines a first vacuum port 100-4. Second end 100-2 has a first opening 100-5.
  • a first piston 102 is slidably received in elongate cylinder 100 through first opening 100-5.
  • a first plunger 104 is attached to, or integrally formed with, first piston 102.
  • First plunger 104 is configured to extend from second end 100-2 of elongate cylinder 100.
  • First plunger 104 has a free end 104-1 having a head 104-2.
  • a first vacuum spring 106 is interposed between second end 100-2 of elongate cylinder 100 and head 104-2 of first plunger 104.
  • First vacuum spring 106 is configured to store mechanical energy when in a compressed state and, in the orientation shown, is configured to bias first piston 102 in the distal direction D1 to establish a vacuum at first vacuum port 100-4.
  • Vacuum pump 92 also is a syringe-type vacuum pump, and is configured identical to vacuum pump 90.
  • Vacuum pump 92 includes an elongate cylinder 110 having a first end 110-1 and a second end 110-2. Extending from first end 110-1 is a tip portion 110-3 that defines a second vacuum port 110-4. Second end 110-2 defines a second opening 110-5.
  • a second piston 112 is slidably received in elongate cylinder 110 through second opening 110-5.
  • a second plunger 114 is attached to, or formed integrally with, second piston 112. Second plunger 114 configured to extend from second end 110-2 of elongate cylinder 110. Second plunger 114 has a free end 114-1 having a head 114-2.
  • a second vacuum spring 116 is interposed between second end 110-2 of elongate cylinder 110 and head 114-2 of second plunger 114.
  • Second vacuum spring 116 is configured to store mechanical energy when in a compressed state and, in the orientation shown, is configured to bias second piston 112 in the distal direction D1 to establish a vacuum at second vacuum port 110-4.
  • Manifold 94 has a first vacuum draw port 94-1, a second vacuum draw port 94-2, and a first vacuum application port 94-3.
  • Manifold 94 has a first one-way valve 94-4 that is coupled in fluid communication with first vacuum draw port 94-1 and a second one-way valve 94-5 that is coupled in fluid communication with second vacuum draw port 94-2.
  • Each of first one-way valve 94-4 and second one-way valve 94-5 is configured to release positive pressure to the atmosphere to facilitate a purge of positive pressure from vacuum pumps 90, 92 during the charging of sampling spring 182, and to close upon establishment of a vacuum by vacuum pumps 90, 92.
  • each of first one-way valve 94-4 and second one-way valve 94-5 is a duckbill valve.
  • Control valve 96 has a third vacuum draw port 96-1, a second vacuum application port 96-2, and a button actuator 96-3.
  • Button actuator 96-3 selectively controls fluid communication between third vacuum draw port 96-1 and second vacuum application port 96-2.
  • control valve 96 is operated by actuation of cannula retract button 40-2 of actuator mechanism 18, which in turn actuates button actuator 96-3 of control valve 96 to apply the vacuum at side sample port 20-3 of stylet 20 simultaneously with movement of cannula 22 in the proximal direction D2 relative to stylet 20 to ready biopsy device 10 for taking a tissue sample.
  • First vacuum port 100-4 of vacuum pump 90 is coupled in fluid communication with first vacuum draw port 94-1 of manifold 94 via flexible connection conduit 98-1.
  • Second vacuum port 110-4 of vacuum pump 92 is coupled in fluid communication with second vacuum draw port 94-2 of manifold 94 via flexible connection conduit 98-2.
  • Flexible connection conduits 98-1 and 98-2 may be in the form of a rubber tubular sleeve, and in the present embodiment, are integral with manifold 94.
  • First vacuum application port 94-3 of manifold 94 is coupled in fluid communication with third vacuum draw port 96-1 of control valve 96 via flexible connection conduit 98-3.
  • Second vacuum application port 96-2 of control valve 96 is coupled in fluid communication with lumen 20-2 at open first end 20-4 of stylet 20 via flexible connection conduit 98-4.
  • Flexible connection conduits 98-3 and 98-4 may be in the form of rubber tubes, and are secured to carriage latch cover member 62 via conduit mounts 62-3, 62-4.
  • vacuum pump 90 is received and mounted, e.g., by press fit and/or adhesive, in first pump mounting opening 66-2 of stylet mount end wall 66 of stylet mounting slider 54, with a proximal cylinder portion 100-6 having first vacuum port 100-4 configured to extend in the proximal direction D2 from stylet mount end wall 66, and a distal cylinder portion 100-7 having second opening 100-5 configured to extend in the distal direction D1 from stylet mount end wall 66.
  • vacuum pump 92 is received and mounted, e.g., by press fit and/or adhesive, in second pump mounting opening 66-3 of stylet mount end wall 66 of stylet mounting slider 54, with a proximal cylinder portion 110-6 having second vacuum port 110-4 configured to extend in the proximal direction D2 from stylet mount end wall 66, and a distal cylinder portion 110-7 having second opening 110-5 configured to extend in the distal direction D1 from stylet mount end wall 66.
  • head 104-2 of plunger 104 of vacuum pump 90 and head 114-2 of plunger 114 of vacuum pump 92 are positioned to be engaged by cannula slide 58.
  • first vacuum spring 106 of vacuum pump 90 and second vacuum spring 116 of vacuum pump 92 is charged (compressed).
  • the compression of first vacuum spring 106 of vacuum pump 90 and second vacuum spring 116 of vacuum pump 92 occurs simultaneously.
  • first vacuum spring 106 and second vacuum spring 116 are accompanied by an evacuation, i.e., purging, of air under positive pressure from elongate cylinders 100, 110 of vacuum pumps 90, 92 via one-way valves 94-4, 94-5 as respective piston/plunger combinations 102/104 and 112/114 are moved in the proximal direction D2.
  • evacuation i.e., purging
  • first vacuum spring 106 and second vacuum spring 116 begin to decompress, and thus bias and tend to move piston/plunger combinations 102/104 and 112/114 of vacuum pumps 90, 92 in the distal direction D1.
  • sampling slide 56 of carriage assembly 50 is configured to be slidably received in the open distal end 60-1 of prime pierce carriage 52.
  • sampling slide 56 has an intermediate slide wall 120, a pair of opposed side walls 122, 124, a latch arm 126, and a latch arm deflection member 128.
  • Intermediate slide wall 120 has a needle hole 120-1, a first pump opening 120-2, a second pump opening 120-3, and a distal face 120-4.
  • a pair of spring attachment loops 120-5, 120-6 extend distally from distal face 120-4.
  • Needle hole 120-1 is configured to slidably receive stylet 20 of biopsy needle 14, with needle hole 120-1 being sized and shaped to serve as a bearing guide surface against stylet 20.
  • the inside diameter of needle hole 120-1 is slightly larger than the outside diameter of stylet 20 in a tolerance range of 0.01 millimeters (mm) to 1.0 mm.
  • First pump opening 120-2 is configured to slidably receive vacuum pump 90 in a loose fit, and in particular, first pump opening 120-2 is configured to freely pass elongate cylinder 100, first plunger 104, and first vacuum spring 106 of vacuum pump 90.
  • Second pump opening 120-3 is configured to slidably receive vacuum pump 92 in a loose fit, and in particular, second pump opening 120-3 is configured to freely pass elongate cylinder 110, first plunger 114, and first vacuum spring 116.
  • the pair of opposed side walls 122, 124 are connected to, or formed integral with, an outer perimeter of intermediate slide wall 120.
  • Side wall 122 extends in both the distal direction D1 and the proximal direction D2 from intermediate slide wall 120, and has a curved cross-section that defines a curved exterior surface 122-1.
  • side wall 124 extends in both the distal direction D1 and the proximal direction D2 from intermediate slide wall 120, and has a curved cross-section that defines a curved exterior surface 124-1.
  • the shape of side walls 122, 124, in combination, correspond to the shape of U-shaped interior surface 64-3 of U-shaped wall 64-1 of carriage slide 60 (see also Fig. 8 ).
  • the curved exterior surfaces 122-1, 124-1 of the pair of opposed side walls 122, 124 of intermediate slide wall 120 are in sliding contact with U-shaped interior surface 64-3 of U-shaped wall 64-1 of carriage slide 60, which serves as an internal longitudinal guide for sampling slide 56.
  • latch arm 126 is configured as a cantilever arm that extends in the distal direction D1 from intermediate slide wall 120, with a free end of the cantilever arm having an upwardly facing catch 130.
  • Latch arm 126 is configured to be longitudinally rigid, and vertically resilient in up and down directions D3, D4 that are substantially perpendicular to the longitudinal extent of latch arm 126.
  • latch arm 126 has a downwardly facing longitudinally extending bi-direction ramp 126-1 having a pair of longitudinally opposed ramp surfaces that define a central apex 126-2.
  • catch 130 is configured as ramp having an upwardly facing ramp surface 130-1 that diverges in the distal direction D1 to define a distal end face 130-2.
  • An extension portion 126-3 of latch arm 126 extends in distal direction D1 beyond distal end face 130-2 to define a proximally facing L-shaped notch having a floor substantially perpendicular to distal end face 130-2.
  • Catch 130 of latch arm 126 is configured to releasably engage latch strike 72 of carriage latch cover member 62 (see also Figs. 8 and 10 ) so as to couple, and prohibit distal movement of sampling slide 56 with respect to carriage slide 60 of carriage assembly 50, until latch arm 126 is released from latch strike 72 of carriage latch cover member 62 by actuation of sample acquisition button 40-3.
  • latch arm deflection member 128 defines a retention channel 128-1 having a downwardly facing ramp surface 128-2 and a ceiling 128-3.
  • Ceiling 128-3 extends substantially perpendicularly from intermediate slide wall 120 in distal direction D1.
  • Downwardly facing ramp surface 128-2 diverges in the proximal direction D2 from an upper surface 128-4 of latch arm deflection member 128 to join ceiling 128-3.
  • cannula slide 58 of carriage assembly 50 also is configured to be slidably received in the open distal end 60-1 of prime pierce carriage 52.
  • cannula slide 58 has a cannula mount end wall 132 and a latch arm 134 that extends in the proximal direction D2 from cannula mount end wall 132.
  • cannula mount end wall 132 is longitudinally spaced distally along longitudinal axis 23 from stylet mount end wall 66 of carriage slide 60.
  • Intermediate slide wall 120 is longitudinally interposed between, and spaced along longitudinal axis 23 from each of, stylet mount end wall 66 and cannula mount end wall 132.
  • cannula mount end wall 132 includes an indexing window 132-1, a proximal face 132-2, and a pair of spring attachment loops 132-3, 132-4.
  • the pair of spring attachment loops 132-3, 132-4 extend proximally from proximal face 132-2.
  • cannula mount tube 136 Extending in proximal direction D2 from cannula mount end wall 132 is a longitudinally extending cannula mount tube 136 having a flared proximal end 136-1, an annular bearing surface 136-2, and a tubular aperture 136-3.
  • Cannula 22 is fixedly mounted in cannula mount tube 136 of cannula mount end wall 132, e.g., by press fit and/or adhesive.
  • cannula 22 has a side wall 22-1 configured to define a lumen 22-2, and has a distal cutting edge 22-3.
  • a proximal portion 22-4 of cannula 22 extends in proximal direction D2 from cannula mount end wall 132 and a distal portion 22-5 of cannula 22 extends in a distal direction D1 from cannula mount end wall 132.
  • Distal portion 22-5 of cannula 22 is slidably received through needle opening 12-1 of housing 12 (see Fig. 1 ).
  • Cannula mount end wall 132 further includes a pair of opposed side walls 138, 140, having a curved cross-section, and each having a respective curved exterior surface 138-1, 140-1 that corresponds to the shape of U-shaped interior surface 64-3 of U-shaped wall 64-1 of carriage slide 60 (see also Figs. 5 and 8 ).
  • the pair of opposed side walls 138, 140 of cannula mount end wall 132 is in sliding contact with U-shaped interior surface 64-3 of U-shaped wall 64-1 of carriage slide 60, which serves as a longitudinal guide for cannula slide 58 within prime pierce carriage 52.
  • indexing window 132-1 positioned centrally under cannula mount tube 136 is indexing window 132-1, which is formed as a rectangular opening that extends through cannula mount end wall 132. Indexing window 132-1 is laterally interposed between two vertically oriented guide channels identified as guide channel 142 and guide channel 144. Guide channels 142, 144 are vertically oriented to be parallel to proximal face 132-2 of cannula mount end wall 132.
  • guide channel 142 is defined by a vertical structure 142-1 having a side slot 142-2
  • guide channel 144 is defined by upper guide opening 144-1 and a lower guide opening 144-2.
  • Indexing window 132-1 is sized to freely receive charge handle latch arm 38 (see Fig. 6 ) without inducing a latching engagement. However, indexing window 132-1 may be selectively intersected, in part, by a portion of an indexing mechanism 150, as described in more detail below, such that the portion of indexing mechanism 150 intersecting indexing window 132-1 may be engaged by catch 38-2 of charge handle latch arm 38 of charge handle 16 on a return stroke of charge handle 16 in distal direction D1.
  • latch arm 134 is configured as a cantilever arm that extends in the proximal direction D2 from cannula mount end wall 132, with a free end of the cantilever arm having an upwardly facing catch 146.
  • Latch arm 134 is configured to be longitudinally rigid, and vertically resilient in up and down directions D3, D4 that are substantially perpendicular to the longitudinal extent of latch arm 134.
  • Catch 146 is configured as ramp having an upwardly facing ramp surface 146-1 that diverges in the proximal direction D2 to define a proximal end face 146-2.
  • an extension portion 134-1 of latch arm 134 extends in proximal direction D2 beyond proximal end face 146-2 to define a proximally facing L-shaped notch having a floor substantially perpendicular to proximal end face 146-2.
  • Catch 146 of latch arm 134 of cannula slide 58 is configured to selectively and releasably engage latch strike 70 of carriage latch cover member 62, and when so engaged, couples cannula slide 58 to carriage slide 60 to prohibit proximal movement of cannula slide 58 with respect to carriage slide 60 of carriage assembly 50, until latch arm 134 is released from latch strike 70 by actuation of cannula retract button 40-2 (see Fig. 1 ).
  • indexing mechanism 150 includes a cannula slide indexer 152 and a sampling slide indexer 154 which cooperate to coordinate the various stages of operation of biopsy device 10.
  • Cannula slide indexer 152 is configured to pivot about cannula mount tube 136 of cannula slide 58
  • sampling slide indexer 154 is configured to move linearly in directions D3 and D4, e.g., up and down, as guided by guide channels 142, 144 of cannula slide 58.
  • directions D3 and D4 are opposite directions, e.g., up and down, and directions D3 and D4 are substantially perpendicular to longitudinal axis 23.
  • cannula slide indexer 152 is selectively operated by a deflection of latch arm 134 of cannula slide 58.
  • cannula slide indexer 152 is configured as an integral structure that includes an axel 156, a lever arm 158, an actuator arm 160, and a torsion spring 162.
  • Axel 156 of cannula slide indexer 152 has a longitudinal extent 156-1 and a cylindrical opening 156-2 configured to be received over bearing surface 136-2 of cannula mount tube 136.
  • the inside diameter of cylindrical opening 156-2 is slightly larger than the outside diameter of bearing surface 136-2 in a tolerance range of 0.01 millimeters (mm) to 1.0 mm so as to permit a pivoting (rotational) motion of cannula slide indexer 152 about cannula mount tube 136, and in turn, to permit pivoting motion about longitudinal axis 23.
  • Axel 156 is retained on bearing surface 136-2 of cannula mount tube 136 by flared proximal end 136-1.
  • Lever arm 158 is radially offset from cylindrical opening 156-2 and in turn is radially offset from longitudinal axis 23 by a radial distance R1.
  • lever arm 158 is positioned and oriented to be selectively engaged by latch arm 134 of cannula slide 58.
  • lever arm 158 has a tangential extent 158-1 and a longitudinal extent 158-2. Tangential extent 158-1 of lever arm 158 is oriented to tangentially extend in a cantilever manner in a direction D5 from axel 156 along a tangent of an imaginary circle corresponding to radial distance R1.
  • Lever arm 158 is configured to be rigid, and may be defined as a plate 158-3 having tangential extent 158-1 and longitudinal extent 158-2, and having a free end 158-4 that defines a longitudinal engagement surface 158-5 having a radius. Longitudinal engagement surface 158-5 is positioned and oriented to be selectively engaged by a bottom surface of latch arm 134 of cannula slide 58 (see also Figs. 13 , and 16-18 ).
  • Actuator arm 160 is radially offset from cylindrical opening 156-2 and in turn is radially offset from longitudinal axis 23 by a radial distance R2.
  • Actuator arm 160 has a tangential extent 160-1. Tangential extent 160-1 of actuator arm 160 is oriented to tangentially extend in a cantilever manner in a direction D6 from axel 156 along a tangent of an imaginary circle corresponding to radial distance R2. Since cannula slide indexer 152 pivots about longitudinal axis 23, direction D6 is relative and the actual direction is dependent upon the angular rotational position of cannula slide indexer 152.
  • direction D6 is in a fixed relationship to direction D5, which are in substantially opposite directions, wherein the term "substantially opposite” means a range of linear (180 degrees) plus or minus 15 degrees.
  • the angular range ⁇ of the fixed relationship of direction D5 relative to direction D6 with respect to longitudinal axis 23 may be in a range of 165 degrees to 180 degrees (linear).
  • Actuator arm 160 is configured to be rigid, and may be defined as a triangular plate 160-2 having tangential extent 160-1, and having a free end 160-3 and a planar engagement surface 160-4.
  • Torsion spring 162 is radially offset from cylindrical opening 156-2 and in turn is radially offset from longitudinal axis 23 by a radial distance R3. Torsion spring 162 has an outward extent 162-1. Outward extent 162-1 of actuator arm 160 is oriented to extend in a cantilever manner from axel 156. In the orientation of components shown in Figs. 5 and 13-14B , torsion spring 162 is configured to bias cannula slide indexer 152 to pivot in a clockwise direction about longitudinal axis 23.
  • torsion spring 162 is configured to be resilient, and may be defined as curved cantilever arm 162-2 having a free end 162-3, wherein a contact surface 162-4 of cantilever arm 162-2 engages a fixed feature of cannula slide indexer 152, such as spring attachment loop 132-3 (see Figs. 16-18 ), where cantilever arm 162-2 applies a counterclockwise force to spring attachment loop 132-3 to bias cannula slide indexer 152 to pivot in the clockwise direction.
  • sampling slide indexer 154 is configured generally as an integral plate-like planar structure, and includes a base 164, a left slide 166, a right slide 168, a window blocking plate 170, a first cam arm 172, a second cam arm 174, and a cantilever spring 176.
  • Left slide 166, right slide 168, window blocking plate 170, first cam arm 172, and second cam arm 174 extend vertically in direction D3 from base 164.
  • Cantilever spring 176 is located below, in direction D4, from base 164.
  • left slide 166 is sized and shaped to be slidably received in side slot 142-2 of guide channel 142 of cannula mount end wall 132 of cannula slide 58.
  • Right slide 168 is sized and shaped to be slidably received in upper guide opening 144-1 and lower guide opening 144-2 of guide channel 144 of cannula mount end wall 132 of cannula slide 58.
  • Window blocking plate 170 may be formed integral with left slide 166.
  • Window blocking plate 170 is configured as a vertically extending plate positioned and oriented to selectively intersect, and partially cover, indexing window 132-1 of cannula mount end wall 132 of cannula slide 58.
  • Window blocking plate 170 includes a side surface 170-1 and a proximal surface 170-2.
  • First cam arm 172 is configured to vertically extend from base 164. First cam arm 172 is laterally interposed between, and spaced from, window blocking plate 170 and second cam arm 174. First cam arm 172 is positioned and oriented to be selectively engaged by engagement surface 160-4 of actuator arm 160 of cannula slide indexer 152. In particular, first cam arm 172 has a free end 172-1 having a radial engagement surface 172-2 that may be engaged by the planar engagement surface 160-4 of actuator arm 160 of cannula slide indexer 152.
  • Second cam arm 174 may be formed integral with right slide 168. Second cam arm 174 is configured to vertically extend from base 164. Second cam arm 174 is positioned and oriented to be selectively engaged by bi-direction ramp 126-1 of latch arm 126 of sampling slide 56. In particular, second cam arm 174 has a free end 174-1 having an engagement surface 174-2 that may be engaged by bi-direction ramp 126-1 of latch arm 126 of sampling slide 56.
  • Cantilever spring 176 is configured as a curved cantilever that extends below a lower portion of base 164, and in turn is located below, base 164, in direction D4. In the orientation of components shown in Figs. 5 , 13 and 15A-18 , cantilever spring 176 is configured to bias sampling slide indexer 154 in direction D3 (in an upward direction).
  • cantilever spring 176 is configured to be resilient, and is defined as curved cantilever arm 176-1 having a free end 176-2, wherein a contact surface 176-3 of cantilever arm 176-1 engages a fixed feature of cannula slide indexer 152, such as longitudinally extending pin 132-5 of cannula slide 58 (see Figs. 16-18 ), where cantilever arm 176-1 applies a downward force in direction D4 to pin 132-5 to bias sampling slide indexer 154 upwardly in direction D3.
  • the motive force provided to power the various functions of biopsy device 10 is provided by at least one cannula retract spring (the present embodiment having a pair of cannula retract springs 180-1, 180-2), a sampling spring 182, and a prime pierce spring 184.
  • cannula retract springs 180-1, 180-2, sampling spring 182, and prime pierce spring 184 may be accomplished by a single spring, or by a plurality of springs.
  • sampling slide 56 and cannula slide 58 are assembled as a subassembly prior to insertion into prime pierce carriage 52 over stylet 20 (see Fig. 8 ).
  • cannula retract spring 180 (two shown in the present embodiment, as 180-1, 180-2), is interposed between, and connected to each of, intermediate slide wall 120 of sampling slide 56 and cannula mount end wall 132 of cannula slide 58.
  • cannula retract spring 180-1 is attached at its ends to spring attachment loop 120-5 of intermediate slide wall 120 of sampling slide 56 and spring attachment loop 132-3 of cannula mount end wall 132 of cannula slide 58.
  • cannula retract spring 180-2 is attached at its ends to spring attachment loop 120-6 of intermediate slide wall 120 of sampling slide 56 and spring attachment loop 132-4 of cannula mount end wall 132 of cannula slide 58.
  • latch arm deflection member 128 of sampling slide is configured for engagement with latch arm 134 of cannula slide 58, and when so engaged, latch arm deflection member 128 deflects, i.e., flexes, latch arm 134 downwardly toward carriage base 64. More particularly, referring also to Figs. 12B and 13 , extension portion 134-1 at the free end of latch arm 134 is positioned for engagement with intermediate slide wall 120 in retention channel 128-1 of intermediate slide wall 120 of sampling slide 56, such that when so engaged, a longitudinal movement of cannula slide 58 in the proximal direction D2 results in a corresponding longitudinal movement of sampling slide 56 in the proximal direction D2.
  • a bottom surface of latch arm 134 of cannula slide 58 engages lever arm 158 to rotate cannula slide indexer 152 counterclockwise about longitudinal axis 23, thus lifting actuator arm 160 and permitting sampling slide indexer 154 to move upward in direction D3 by action of cantilever spring 176, thereby positioning window blocking plate 170 to block a portion, e.g., the lower left quadrant, of indexing window 132-1 of cannula slide 58, such that window blocking plate 170 may be engaged by catch 38-2 of charge handle latch arm 38 of charge handle 16 (see also Fig. 6 ).
  • latch arm 134 When cannula slide 58 is moved in distal direction D1 away from sampling slide 56, latch arm 134 disengages from latch arm deflection member 128 and, due to its resiliency, latch arm 134 returns to its non-deflected position, i.e., latch arm 134 moves back to its original non-flexed position.
  • cannula slide indexer 152 rotates counterclockwise about longitudinal axis 23 to its full clockwise position via the torsional force exerted by torsion spring 162, thus moving sampling slide indexer 154 downwardly in direction D4, such that window blocking plate 170 no longer blocks a portion of indexing window 132-1 of cannula slide 58.
  • sampling slide 56 is spaced a minimum allowable distance from cannula slide 58 and places each of cannula retract springs 180-1, 180-2 in a contracted state, but each of cannula retract springs 180-1, 180-2 may be in a slight state of extension.
  • the term "slight state of extension” means the storage of a force that is less than 10 percent of the total force available from springs 180-1, 180-2 in a charged (extended) state.
  • charge or “charged” means the storage of mechanical energy by one or more springs.
  • the term “charging” means the act of storing mechanical energy in a storage device in the form of one or more springs.
  • cannula retract springs 180-1, 180-2 are charged to a charged state to store mechanical energy when cannula retract springs 180 are in an extended state.
  • cannula retract springs 180-1, 180-2 are releasably held in the charged (extended) state under the condition: (a) catch 130 of latch arm 126 of sampling slide 56 is engaged with latch strike 72 of carriage latch cover member 62 and (b) catch 146 of latch arm 134 of cannula slide 58 is engaged with latch strike 70 of carriage latch cover member 62.
  • cannula retract springs 180 are released from the charged (extended) state and exert a contraction force to bias and move cannula mount end wall 132 of cannula slide 58, and in turn cannula 22, in the proximal direction D2 toward sampling slide 56, which in turn exposes side sample port 20-3 of stylet 20.
  • sampling spring 182 is interposed between stylet mount end wall 66 of carriage slide 60 of prime pierce carriage 52 and intermediate slide wall 120 of sampling slide 56.
  • sampling spring 182 is a coil spring that is charged, via a compression of sampling spring 182, to store mechanical energy when held in a charged (compressed) state.
  • Sampling spring 182 is held, i.e., retained, in the charged (compressed) state, when catch 130 of latch arm 126 of sampling slide 56 is engaged with latch strike 72 of carriage latch cover member 62.
  • sampling spring 182 exerts an expansion force to bias and move sampling slide 56, and in turn cannula slide 58 and cannula 22, in distal direction D1.
  • prime pierce spring 184 is interposed between intermediate wall 32 of housing 12 and prime pierce mount post 64-9 of carriage base 64 of carriage slide 60 of prime pierce carriage 52.
  • Prime pierce spring 184 is charged to a charged state to store mechanical energy when prime pierce spring 184 is in a compressed state.
  • Prime pierce spring 184 is releasably held in the charged (compressed) state when carriage latch arm 74 of carriage latch cover member 62 is engaged with carriage latch strike 44 of actuator mechanism 18 (see also Fig. 7B ).
  • biopsy device 10 is described as being primed.
  • prime pierce spring 184 When prime pierce spring 184 is released from the charged (compressed) state, which enters a "pierce” condition, prime pierce spring 184 exerts an expansion force to fire, i.e., to rapidly move, carriage assembly 50 carrying biopsy needle 14, as a whole, in the distal direction D1. In other words, the firing of carriage assembly 50 carrying biopsy needle 14 simultaneously moves stylet 20 and cannula 22 in distal direction D1 such that biopsy needle 14 punctures the tissue of a patient at the desired location.
  • a user grasps charge handle 16 and manually effects a proximal stroke, i.e., a retraction, of charge handle 16 relative to housing 12 by pulling charge handle 16 in the proximal direction D2 from the home position to the retracted position, which in turn charges (extends) biasing springs 39-1, 39-2. While a plurality of biasing springs are shown in the present embodiment, those skilled in the art will recognize that the effect of biasing springs 39-1, 39-2 may be accomplished by a single spring or by multiple springs.
  • the user releases charge handle 16, and biasing springs 39-1, 39-2 contract to effect movement of charge handle 16 relative to housing 12 in a return (distal) stroke in the distal direction D1 to return charge handle 16 to the home position.
  • Figs. 20-26 shows biopsy 10 with the upper case portion 24 removed to expose carriage assembly 50, and with carriage latch cover member 62 disconnected from carriage slide 60 of prime pierce carriage 52 to expose sampling slide 56 and cannula slide 58, so as to show the various positional relationships of components during various stages of preparing biopsy device 10 for use in taking a biopsy sample from a patient.
  • Fig. 20 shows biopsy device 10 when biopsy device 10 is new, and after biopsy device has been fully cycled in taking a biopsy. As shown, all of the biasing springs 39-1, 39-2, vacuum springs 106, 116, cannula retract springs 180-1, 180-2, sampling spring 182, and prime pierce spring 184 are in a discharged state.
  • sampling slide 56 and cannula slide 58 are moved collectively in the proximal direction D2 relative to carriage slide 60 to simultaneously charge vacuum springs 106, 116 and sampling spring 182.
  • cannula slide indexer 152 and sampling slide indexer 154 of indexing mechanism 150 are positioned as shown in Fig.
  • the first retraction (proximal) stroke of the charge handle 16 toward to the retracted position moves the sampling slide 56 and the cannula mount end wall 132 of cannula slide 58 that carries the cannula 22 in unison, by virtue of the latch arm 134 being engaged with the intermediate slide wall 120 of sampling slide 56, in the proximal direction D2 to charge (compress) sampling spring 182.
  • the proximal movement of cannula mount end wall 132 of cannula slide 58 moves the respective piston/plunger combinations 102/104 and 112/114 of vacuum pumps 90, 92 in the proximal direction D2 to charge (compress) first vacuum spring 106 of vacuum pump 90 and second vacuum spring 116 of vacuum pump 92.
  • vacuum springs 106, 116 are retained in their charged state only by the internally generated vacuum in vacuum pumps 90, 92. As the vacuum is released, e.g., by operation of button 40-2 of actuator mechanism 18, then vacuum springs 106, 116 will tend to return to their non-charged state.
  • biasing springs 39-1, 39-2 discharge to effect a first return (distal) stroke of charge handle 16 to return charge handle 16 to the home position, and to sequence the indexing mechanism 150 to the cannula retract position as depicted in Fig.
  • sampling slide indexer 154 moves in upward direction D3 by the force exerted by cantilever spring 176, to in turn laterally positioning window blocking plate 170 of sampling slide indexer 154 over a portion, e.g., the lower left quadrant, of indexing window 132-1 of cannula slide 58.
  • charge handle latch arm 38 of charge handle 16 attempts to pass through indexing window 132-1 of cannula slide 58, however this time the tapered nose portion of catch 38-2 of charge handle latch arm 38 slidably engages side surface 170-1 of window blocking plate 170 of sampling slide indexer 154 (see Fig. 17 ), and deflects around window blocking plate 170 to then pass through indexing window 132-1 of cannula slide 58.
  • charge handle latch arm 38 of charge handle 16 is releasably coupled to cannula mount end wall 132 of cannula slide 58 via indexing mechanism 150.
  • biasing springs 39-1, 39-2 discharge to effect a second return (distal) stroke of charge handle 16 to return charge handle to the home position.
  • catch 38-2 of charge handle latch arm 38 catches proximal surface 170-2 of window blocking plate 170 of sampling slide indexer 154 (see Fig. 17 ), which in turn pulls cannula mount end wall 132 of cannula slide 58 in distal direction D1 away from intermediate slide wall 120 of sampling slide 56, and cannula 22 is moved by cannula mount end wall 132 in the distal direction D1 to close side sample port 20-3 of stylet 20.
  • cannula retract springs 180-1, 180-2 The movement of cannula mount end wall 132 of cannula slide 58 in distal direction D1 away from intermediate slide wall 120 of sampling slide 56 extends cannula retract springs 180-1, 180-2 to the charged (extended) state.
  • the force exerted by biasing springs 39-1, 39-2 and any mechanical advantage associated therewith, if any, must be greater than the force exerted by cannula retract springs 180-1, 180-2 and any mechanical advantage associated therewith, if any, so as to return charge handle 16 to the home position while pulling cannula slide 58 to its latched position.
  • cannula slide indexer 152 allows cannula slide indexer 152 to pivot clockwise by the force exerted by torsion spring 162 about longitudinal axis 23, which in turn moves actuator arm 160 downwardly in direction D4 to move window blocking plate 170 of sampling slide indexer 154 downwardly in direction D4, thus opening indexing window 132-1 of cannula slide 58, thus facilitating the release of charge handle 16 from cannula slide 58.
  • catch 146 of latch arm 134 of cannula slide 58 releasably engages latch strike 70 of carriage latch cover member 62 to retain cannula retract springs 180 in the charged (extended) state. Also, catch 130 of latch arm 126 of sampling slide 56 remains engaged with latch strike 72 of carriage latch cover member 62.
  • sampling slide 56 and cannula slide 58 are spaced at a maximum separation distance from one another, and each of sampling slide 56 and cannula slide 58 are latched to maintain the maximum separation distance, until catch 146 of latch arm 134 of cannula slide 58 is released by actuation of cannula retract button 40-2.
  • a third retraction (proximal) stroke of charge handle 16 in proximal direction D2 moves carriage assembly 50 as a whole in the proximal direction D2 to charge (compress) prime pierce spring 184.
  • cannula slide indexer 152 and sampling slide indexer 154 of indexing mechanism 150 are positioned as shown in Fig. 18 , such that charge handle latch arm 38 of charge handle 16 (see Fig.
  • Biopsy device 10 is now fully primed, with all of vacuum spring 106, 116, cannula retract springs 180-1, 180-2, sampling spring 182, and prime pierce spring 184 being in a charged state, and biopsy device is ready for operation in performing a vacuum-assisted biopsy procedure with a piercing shot function. It is to be understood that in the event that the physician performing the biopsy procedure does not choose to perform a piercing shot function, then the third retraction/return (proximal/distal) strokes of charge handle 16 can be omitted.
  • Prime pierce spring 184 In the piercing shot mode of the state of biopsy device 10 shown in Fig. 26 , wherein prime pierce spring 184 is charged during the third retraction (proximal) stroke, referring to Figs. 1 , 7B and 10 , an actuation of pierce button 40-1 releases carriage latch arm 74 from carriage latch strike 44, so as to release prime pierce spring 184 from the charged (compressed) state to effect a transition of biopsy device 10 from the state shown in Fig. 26 to that shown in Fig. 24 .
  • Prime pierce spring 184 in turn exerts an expansion force to rapidly move carriage assembly 50 carrying stylet 20 and cannula 22, in unison, in the distal direction D1 to pierce tissue and to position biopsy needle 14 at the biopsy site within the patient.
  • an actuation of cannula retract button 40-2 releases latch arm 134 of cannula slide 58 from latch strike 70 of carriage latch cover member 62, thereby releasing cannula retract springs 180 from the charged (extended) state to exert a compressive force to move cannula slide 58 and cannula 22 in the proximal direction D2 to in turn open side sample port 20-3 of stylet 20 to transition biopsy device 10 from the state shown in Fig. 24 to that shown in Fig. 22 .
  • cannula retract button 40-2 further actuates button actuator 96-3 of vacuum system 54 to open control valve 96 to apply the vacuum generated by vacuum pumps 90, 92 to flexible connection conduit 98-4 coupled in fluid communication with lumen 20-2 of stylet 20, and in turn to lumen 20-2 at side sample port 20-3 of stylet 20. Tissue in the vicinity of side sample port 20-3 of stylet 20 will be drawn by the vacuum into side sample port 20-3.
  • an actuation of sample acquisition button 40-3 releases catch 130 of latch arm 126 from latch strike 72 of carriage latch cover member 62, thereby releasing sampling spring 182 from the charged (compressed) state to exert an expansion force to rapidly move cannula slide 58 carrying cannula 22 in the distal direction D1 to transition biopsy device 10 from the state shown in Fig. 22 to that shown in Fig.
  • cannula 22 severs the tissue at side sample port 20-3 of stylet 20 and covers over, i.e., closes, side sample port 20-3, thereby retaining any tissue drawn into side sample port 20-3 of stylet 20 as the tissue sample, thus completing the tissue sample collection.
  • biopsy needle 14 is removed from the patient, and the first retraction (proximal) stroke is repeated so as to retract cannula 22 to open side sample port 20-3 of stylet 20. Since vacuum springs 106, 116 and sampling spring 182 are charged during the first retraction stroke of charge handle 16, then if no further tissue samples are desired, the vacuum may be purged by actuating cannula retract button 40-2, and sampling spring 182 may be discharged by actuating sample acquisition button 40-3. However, if a further tissue sample is desired, then the second retraction and return strokes are repeated to charge cannula retract springs 180-1, 180-2.
  • Biopsy device 10 is now ready for a manual insertion into the patient, i.e., no piercing shot. However, if the piercing shot mode is desired, then the third retraction stroke of charge handle 16 is repeated to charge prime pierce spring 184 and prime biopsy needle 14 to the fully retracted position for the simultaneous firing of stylet 20 and cannula 22 into the tissue of the patient.

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CA2984601A1 (en) 2016-11-10
US11179142B2 (en) 2021-11-23
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US20200015796A1 (en) 2020-01-16
US20180103939A1 (en) 2018-04-19
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US10463350B2 (en) 2019-11-05
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